Australia TGA ARTG record

Clinical chemistry autoimmune IVDs

Australia TGA ARTG Registered Device · Southern Cross Diagnostics Pty Ltd · Orgentec Diagnostika GmbH · Class IIa · Started May 07, 2012

Good Name: Southern Cross Diagnostics Pty Ltd - Clinical chemistry autoimmune IVDs

Device classification

Risk Class: Class IIa
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: May 07, 2012
Effective Date: May 07, 2012

Sponsor

Name: Southern Cross Diagnostics Pty Ltd

Manufacturer

Name: Orgentec Diagnostika GmbH
Country: Germany
Address: Carl-Zeiss-Strasse 49-51, Mainz, 55129

Intended purpose

IVDs that are intended to be used for the qualitative and/or quantitative determination of autoimmune markers in a clinical specimen.

About this record

Access comprehensive regulatory information for Clinical chemistry autoimmune IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Southern Cross Diagnostics Pty Ltd, manufactured by Orgentec Diagnostika GmbH in Germany. The device registration started on May 07, 2012.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.